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AMA proposal would make all clinical trial results public

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CHICAGO — A proposal to be considered by the American Medical Association would seek to make public the results of all clinical trials of pharmaceuticals, even those that report unfavorable data about a drug, according to a report by the Associated Press.

The proposal is one of more than 250 to be considered at the AMA’s annual meeting this week, the AP said.

According to the AP report, part of the proposal would ask the Department of Health and Human Services to form a national drug registry for all clinical studies. Critics of the proposal said a public research registry could lead to patient misinterpretation, the AP said.

The proposal relates to a controversy started earlier this month, when pharmaceutical giant GlaxoSmithKline was sued by New York state for allegedly withholding negative clinical trial data about the effect of its antidepressant Paxil on children and teens. The New York state attorney general’s office claimed that of five studies conducted on children in 1998, only one was released. The remaining four showed that the drug was ineffective and that it increased suicide risks, according to an article in The New York Times. GlaxoSmithKline said that it has made all studies available to government regulatory agencies.

Both the Journal of the American Medical Association and the New England Journal of Medicine have voiced support for a national registry, according to the AP.